Institutional Review Board Jurisdiction

The Institutional Review Board (IRB) considers human subject research proposals involving Salem faculty, students, and staff as researchers or research subjects. “Research” means a systematic investigation designed to develop or contribute to generalizable knowledge (Final Common Rule, section 102L). Salem College requires that proposals for research activities involving human subjects be submitted for review and approval or exemption by the IRB prior to initiation of research.

Scope of IRB Review

The Salem College IRB considers three principal issues when evaluating a proposal:

1. Are the design and procedures sufficient to justify the involvement of human subjects?

2. Are the rights of the human subjects safeguarded?

3. Do the procedures selected involve the least amount of necessary risk?

Levels of IRB Review

1. A research proposal that requires IRB approval must be reviewed by the full committee, whether at a convened IRB meeting (held once a month during the fall and spring semesters) or through an expedited review. Possible outcomes of the review are (i) approval, (ii) request for minor modifications to be affirmed by the IRB Chair for subsequent approval, (iii) request for significant modifications to be reviewed again by the full committee, or (iv) disapproval.

2. A research proposal that requires IRB exemption with limited review will be reviewed by an individual member of the IRB chosen by the IRB Chair. The individual reviewer may request for modifications to be made to the proposal prior to exemption being granted. If the applicant disagrees with the modifications requested, then the applicant may request for the proposal to be reviewed by the full committee.

3. A research proposal that requires IRB exemption without limited review will only be reviewed by the IRB Chair to confirm that neither limited review nor full review are required. The IRB will not request any modifications to the proposal in this case.

To Apply for IRB Approval or Exemption

To apply for exemption without limited review:

1. Complete the Short IRB Proposal Form (Word) and email your proposal as an attachment to irb@salem.edu.

2. Complete CITI Program training (or equivalent training) and submit proof of completion to irb@salem.edu.

To apply for exemption with limited review or approval:

1. Complete the Long IRB Proposal Form (Word) and submit a hard copy of your proposal to the Dean of the College.

2. Email your proposal as an attachment (formatted as a Word document) to irb@salem.edu.

3. Complete CITI Program training (or equivalent training) and submit proof of completion to irb@salem.edu.

If you are unsure whether you should submit the long proposal form or the short proposal form, please read the flow chart linked here.

The submitted proposal will undergo an initial review by the IRB Chair to determine whether (1) it requires review and approval from the full committee, (2) it requires limited review and exemption by a single IRB member, or (3) it is exempt without requiring a limited review. If your project is not eligible for exemption but involves only minimal risk to the participants, then it might be eligible for an expedited review. Projects that are neither eligible for exemption nor eligible for expedited review can only be reviewed in the next convened IRB meeting after they are submitted, and therefore these proposals should be submitted well in advance of the anticipated start date of the project.

You are not required to complete CITI Program training prior to submitting your proposal, but you are strongly encouraged to do so. Approval or exemption cannot be granted until the training is complete.

Projects That Do Not Require IRB Approval or Exemption

Not all projects that involve human subjects qualify as research. Some examples of projects that are not considered research (and hence do not require IRB review of any kind unless it is required by your faculty supervisor or program of study) are listed below (Final Common Rule, section 102L).

• Class assignments for which the results of the project will be confined to the class for which the project is conducted (i.e., the results will not be published or presented in any forum outside the class, such as the Celebration of Academic Excellence or the Graduate Research Symposium)

• Surveys intended to gauge interest for club activities

• Surveys conducted by Salem College faculty, administration, or staff for which the results will only be used internally within the College and not published, publicly presented, or shared with other institutions

• Oral history or biography

• Historical scholarship

• Literary criticism

• Legal research

• Journalism – “activities focused on the collection, verification, and reporting of information or facts on current events, trends, newsworthy issues, or stories about people or events, with no intent to develop or test a hypothesis” (Cornell IRB)

If you are unsure whether your project fits into any of the categories above, you should email the IRB Chair with a description of your project to receive assistance in determining if your project qualifies as research.

Projects That Require IRB Exemption Without Limited Review

Projects that qualify for this level of review commonly come from the following two categories, as described from section 104 of the Final Common Rule:

1. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.

   2. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.

2. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Projects That Require IRB Exemption With Limited Review

Projects that qualify for this level of review commonly come from the following category, as described in section 104 of the Final Common Rule:

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) such that both of the following criteria are met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.

2. Disclosure of data could reasonably place subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation.

Projects That Require IRB Approval

Human subject research projects that do not qualify for exemption must undergo review and approval by the full IRB. These are projects that do not fit into any of the exemption categories mentioned above or otherwise outlined in section 104 of the Final Common Rule.

Renewing or Revising Research Proposals

Approval from the IRB for a research proposal is valid for one year from the date on which it is issued. To renew IRB approval of a project past its original end date, the researcher should make a request to the Chair of the IRB at least one month before the expiration date.

If a researcher wishes to substantively change a project after it has received IRB approval or exemption, then the researcher should explain the necessary changes in an email to the IRB and submit a revised proposal form indicating the changes. Substantive changes may not be initiated without IRB review and approval or exemption except when necessary to eliminate apparent immediate hazards to research participants.